A global medical device company is seeking a Human Factors Engineer to join their Research and Development team on a contract basis. You will collaborate with R&D engineers to conduct field research and case studies, applying findings to human interface requirements for concept refinement, use-related risk assessment, and usability validation with intended users. Your role will support two of their latest projects.
Essential skills:
* Experience with Human Factors/Usability in medical devices, familiarity with IEC Usability standards, AAMI Human Factors standards, and/or FDA Human Factors Guidance.
* Proven ability in writing formative and summative usability test protocols and reports, designing instructions for use (IFU) documents, and conducting user/environment research, scenario development, and documentation.
* Skilled in usability evaluations, facilitation, observation, and supporting risk management processes.
Desirable skills:
* Experience compiling the usability engineering file (UEF) for regulatory submissions, including use specifications, error analysis, UOUP, task analysis, and uFMEA.
* Knowledge of medical device usability regulatory standards and requirements.
* Ability to lead Human Factors/Usability activities independently with minimal supervision.
The position is available ASAP/August, initially for 12 months with potential extension. It is based in Limerick with a requirement of 1 day onsite per week; remaining work can be remote. The hourly rate ranges from €45-55, depending on experience. Please inform us of any expenses for rate consideration.
If interested, please send your latest CV for further discussion.
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